Functieomschrijving

Your efforts aim to ensure proper and timely execution of outsourced manufacturing activities that are part of new drug development tracks. You operate at the technical interface with external partners. This includes planning, technology transfer and compliance monitoring according to applicable quality standards.

As Process Engineer Manufacturing you use your technical knowledge and project management skills to select, monitor and manage CMO's that perform GMP manufacturing activities for the organization. This is done for several drug development tracks.

- You contribute to the contract manufacturing organization (CMO) selection process by assessing accountability, technical readiness, compliance, fit-to-plant activities and, if required, technology transfer runs
- By liaising between subject matter experts from Quality Assurance, internal stakeholders and external contacts at the CMO, you ensure technical feasability and that the required quality level is reached
- Moreover, you are responsible for the process description, review of the documentation and technical oversight manufacturing, you actively contribute to this
- In case of deviations, events or non-compliance, you initiate CAPAs and ensure aligned expectations between the company and the partner
- As Manager Process Development you are responsible for (parts of) outsourced process development, optimization, characterization and validation. This includes writing study plans and reports
- This means that you work both at the company, but also that you pay on-site visits to clients and CMO's abroad
- For more senior candidates, this role can include supplemental quality, regulatory, technical and business aspects

Profiel

Opleiding

HBO

Ervaring

Ervaren (3 - 8 jaar)

For the Process Engineer Manufacturing position we are looking for an enthusiastic candidate who meets the following qualifications:

- At least a Bachelor (BSc) or Master (MSc) degree in a relevant field of study
- You have at least 5 years of work experience in process development of (bio)pharmaceutical products or a similar manufacturing environment
- Although pharmaceutical experience is not a strict requiirement, it is desirable if you have experience with process development, technology transfers, GMP manufacturing, outsourcing, troubleshooting, conducting audits and site visits
- You are a strong team player and well-able to establish and maintain both internal and external contacts
- Your experience enables you to decide when you should shedule a CMO visit and when not
- You are fluent in English. Dutch is considered a plus. Moreover, you are willing to travel (up to 25%) for up to two weeks for on-site visits

Aanvullende informatie

- A contract via Checkmark Labrecruitment for one year
- Intention to extend this contract thereafter
- Available for at least 4 days per week
- Willing to travel (up to 25% with a maximum stay abroad up to two weeks)